Studies included in the pooled analysis of patients in the higher-risk subgroup treated with acalabrutinib-based regimens
| . | Study . | Study description . | Data cutoff date . | Number of patients treated with A-based regimens (N = 808) . | ||
|---|---|---|---|---|---|---|
| del(17p)/TP53m (n = 283) . | uIGHV (n = 712) . | CK∗ (n = 239) . | ||||
| TN CLL (n = 320) | ACE-CL-001 TN cohort NCT02029443 | Phase 1/2:A monotherapy in TN CLL/SLL | 15 July 2021 | 12 | 57 | 12 |
| ACE-CL-003 TN cohort (cohort 2) NCT02296918 | Phase 1b/2: A + O in TN CLL | 13 June 2021 | 4 | 9 | 8 | |
| ELEVATE-TN CL-007 NCT02475681 | Phase 3: A ± O vs O + Clb in TN CLL | 01 October 2021 | 48 | 221 | 59 | |
| Proportion of higher-risk genomic subgroup in TN cohort, n/N (%)† | 64/283 (23) | 287/712 (40) | 79/239 (33) | |||
| R/R CLL (n = 488) | ACE-CL-001 R/R cohort NCT02029443 | Phase 1/2:A monotherapy in R/R CLL/SLL | 15 July 2021 | 35 | 81 | 20 |
| ACE-CL-003 R/R cohort‡ (cohort 1) NCT02296918 | Phase 1b/2: A + O in R/R CLL | 13 June 2021 | 5 | 17 | 14 | |
| ELEVATE-RR CL-006 NCT02477696 | Phase 3:A monotherapy vs ibrutinib in R/R CLL | 15 September 2020 | 135 | 219 | 123 | |
| ASCEND CL-309 NCT02970318 | Phase 3:A monotherapy vs IdR/BR in R/R CLL | 03 September 2021 | 44 | 108 | 3 | |
| Proportion of higher-risk genomic subgroup in R/R cohort, n/N (%)† | 219/283 (77) | 425/712 (60) | 160/239 (67) | |||
| . | Study . | Study description . | Data cutoff date . | Number of patients treated with A-based regimens (N = 808) . | ||
|---|---|---|---|---|---|---|
| del(17p)/TP53m (n = 283) . | uIGHV (n = 712) . | CK∗ (n = 239) . | ||||
| TN CLL (n = 320) | ACE-CL-001 TN cohort NCT02029443 | Phase 1/2:A monotherapy in TN CLL/SLL | 15 July 2021 | 12 | 57 | 12 |
| ACE-CL-003 TN cohort (cohort 2) NCT02296918 | Phase 1b/2: A + O in TN CLL | 13 June 2021 | 4 | 9 | 8 | |
| ELEVATE-TN CL-007 NCT02475681 | Phase 3: A ± O vs O + Clb in TN CLL | 01 October 2021 | 48 | 221 | 59 | |
| Proportion of higher-risk genomic subgroup in TN cohort, n/N (%)† | 64/283 (23) | 287/712 (40) | 79/239 (33) | |||
| R/R CLL (n = 488) | ACE-CL-001 R/R cohort NCT02029443 | Phase 1/2:A monotherapy in R/R CLL/SLL | 15 July 2021 | 35 | 81 | 20 |
| ACE-CL-003 R/R cohort‡ (cohort 1) NCT02296918 | Phase 1b/2: A + O in R/R CLL | 13 June 2021 | 5 | 17 | 14 | |
| ELEVATE-RR CL-006 NCT02477696 | Phase 3:A monotherapy vs ibrutinib in R/R CLL | 15 September 2020 | 135 | 219 | 123 | |
| ASCEND CL-309 NCT02970318 | Phase 3:A monotherapy vs IdR/BR in R/R CLL | 03 September 2021 | 44 | 108 | 3 | |
| Proportion of higher-risk genomic subgroup in R/R cohort, n/N (%)† | 219/283 (77) | 425/712 (60) | 160/239 (67) | |||
A, acalabrutinib; BR, bendamustine plus rituximab; Clb, chlorambucil; IdR, idelalisib plus rituximab; O, obinutuzumab; SLL, small lymphocytic lymphoma.
CK was defined as having ≥3 chromosomal abnormalities with ≥1 structural abnormality excluding inversion of chromosome 9.
Genomic categories are not mutually exclusive.
Data in the R/R cohort of CL-003 were included only in demographics/baseline characteristics, study disposition, and safety analyses (Tables 2 and 3; supplemental Tables 1 and 2); CL-003 data were not included in the R/R efficacy analyses.